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NCT01592383 · REGISTRY CONDITION SEARCH

Erlotinib Hydrochloride in Treating Patients With Malignant Peritoneal Mesothelioma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2018-10-16

The purpose of this study is to test the drug erlotinib (erlotinib hydrochloride) in people with malignant peritoneal mesothelioma who have a specific genetic mutation in their cancer. Erlotinib has been approved by the United States Food and Drug Administration (FDA) for other cancers, but erlotinib has not been approved for malignant peritoneal mesothelioma. This research is being done because there is no current standard treatment for malignant peritoneal mesothelioma and the study doctors want to see how erlotinib affects malignant peritoneal mesothelioma.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Objective Response Rate

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outcome · POSTED

PFS

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outcome · POSTED

OS

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outcome · POSTED

Toxicity

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outcome · POSTED

Disease Control Rate - SD + PR + CR

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outcome · POSTED

EGFR Mutations Percentage

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Histologically- or cytologically-confirmed malignant peritoneal mesothelioma; epithelial, sarcomatoid, biphasic, or well-differentiated papillary subtypes are allowed. * A tumor block or 10 unstained slides must be available for determining EGFR mutational status; only those patients who have a mutation of the EGFR tyrosine kinase domain will be able to enroll in this study. * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral computed tomography (CT) scan. * No prior use of EGFR tyrosine kinase inhibitors or monoclonal antibodies; all other prior treatments are allowed if \>= 4 weeks since treatment completed, including chemotherapy (systemic or intraperitoneal), radiation therapy, and/or surgery; there is no limit on the number of previous treatments allowed. * Life expectancy of greater than 3 months. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Leukocytes \>= 2,000/mcL. * Absolute neutrophil count \>= 1,500/mcL. * Platelets \>= 100,000/mcL. * Total bilirubin =\< 1.5 X institutional upper limit of normal (ULN). * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 2.5 X institutional ULN. * Creatinine =\< 2 X institutional ULN OR creatinine clearance \>= 30 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal. * The effects of erlotinib on the developing human fetus at the recommended therapeutic dose are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * Ability to understand and the willingness to sign a written informed screening and treatment consent. Exclusion Criteria: * Chemotherapy, radiotherapy, or surgery within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. * Patients may not be receiving any other investigational agents. * Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop. progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib. * EGFR-mutation negative tumor tissue as determined by sequencing; if an individual tissue test result is inconclusive (unable to be determined), it will be considered negative for study eligibility purposes. * History of previous malignancy excluding non-melanoma skin lesions and in-situ cervical cancer; patients with other malignancies are eligible if they have been disease free for \>= 3 years. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant women are excluded from this study because it is unknown if erlotinib poses a potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with erlotinib, breastfeeding should be discontinued if the mother is treated with erlotinib. * Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with erlotinib; in addition, these patients are at increased risk of lethal infections; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated. * Inability to tolerate or absorb an oral medication due to any cause, including but not limited to malabsorption syndromes.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive erlotinib hydrochloride PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: erlotinib hydrochloride
    label
    Treatment (enzyme inhibitor therapy)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (enzyme inhibitor therapy)
    description
    Given PO
    name
    erlotinib hydrochloride
    other Names
    1. CP-358,774
    2. erlotinib
    3. OSI-774
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
2
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Objective Response Rate is calculated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
    measure
    Objective Response Rate
    time Frame
    1 year
secondary Outcomes
  1. description
    Progression free survival (PFS) defined as time from study enrollment until disease progression or death.
    measure
    PFS
    time Frame
    1 year
  2. description
    Overall survival measured as the time from study enrollment until death.
    measure
    OS
    time Frame
    1 year
  3. description
    Toxicity is calculated in terms of adverse events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) criteria version 4.0
    measure
    Toxicity
    time Frame
    30 days from the last dose of study drug
  4. description
    Disease Control Rate - SD + PR + CR is calculated as the percentage of patients with either complete response (CR: disappearance of all target lesions), or with partial response (PR: at least 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter of target lesions), or stable disease (SD: neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease of an increase of at least 20% in the sum of the longest diameter of the target lesions taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of one or more new lesions).
    measure
    Disease Control Rate - SD + PR + CR
    time Frame
    1 year
  5. description
    EGFR Mutations Percentage is calculated as the percentage of patients who have activating EGFR mutations among all screened patients.
    measure
    EGFR Mutations Percentage
    time Frame
    Baseline
Full study description
brief Summary
The purpose of this study is to test the drug erlotinib (erlotinib hydrochloride) in people with malignant peritoneal mesothelioma who have a specific genetic mutation in their cancer. Erlotinib has been approved by the United States Food and Drug Administration (FDA) for other cancers, but erlotinib has not been approved for malignant peritoneal mesothelioma. This research is being done because there is no current standard treatment for malignant peritoneal mesothelioma and the study doctors want to see how erlotinib affects malignant peritoneal mesothelioma.
detailed Description
PRIMARY OBJECTIVES: I. To determine the objective response rate (complete response \[CR\] + partial response \[PR\]) of erlotinib in malignant peritoneal mesothelioma (MPeM) patients who have epidermal growth factor receptor (EGFR) mutations. SECONDARY OBJECTIVES: I. To determine the percentage of patients with MPeM who have EGFR mutations. II. To characterize asbestos exposure history and other clinical parameters of patients with MPeM who do or do not have EGFR mutations. III. To determine the disease control rate (CR + PR + stable disease \[SD\]) of MPeM patients who have EGFR mutations and are treated with erlotinib. IV. To determine the progression-free survival (PFS) of MPeM patients who have EGFR mutations and are treated with erlotinib. V. To determine the median overall survival (OS) of MPeM patients who have EGFR mutations and are treated with erlotinib. VI. To evaluate toxicity in MPeM patients who have EGFR mutations and are treated with erlotinib. TERTIARY OBJECTIVES: I. To characterize the specific EGFR mutations observed in MPeM patients. II. To correlate tumor markers (cancer antigen \[CA\] 125 and soluble mesothelin-related peptide \[SMRP\]) with response rate, PFS, and OS in MPeM patients treated with erlotinib. III. To correlate immunohistochemical staining of EGFR, phosphorylated (p)-EGFR, MET (Metastasis), E-cadherin, vimentin, and CBL (Casitas B-lineage Lymphoma)with EGFR mutational status and, if present, particular EGFR mutation noted. IV. To correlate immunohistochemical staining of EGFR, p-EGFR, MET, E-cadherin, vimentin, and CBL with response rate, PFS, and OS in MPeM patients treated with erlotinib. OUTLINE: Patients receive erlotinib hydrochloride orally (PO) once daily (QD). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
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      true
      id
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      occurrences
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        exact text
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        start
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      offset unit
      unicode_code_points
      query cond
      Malignant Mesothelioma
      query disease state id
      ds-malignant-mesothelioma
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-malignant-mesothelioma-000.json
      source file sha256
      0a018dbf1aa46f57978b6d16aa19b94d76d6d65cf1e297e889c8e599fef1fab1
      source json pointer
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      source kind
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      source string basis
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      source string sha256
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    Preserved source evidence · Not medical advice